What Is a Clinical Trial?

Between headlining health scares and ongoing healthcare
debates, it’s easy to forget that, at heart, medicine is dedicated to improving
peoples’ lives. Doctors, researchers and medical innovators are constantly
looking for new medicines and treatments to help us live healthier, safer and longer.
One way to accomplish those goals? Clinical trials.

“Clinical trials are an integral part of any learning
healthcare system that’s trying to improve the long-term outcomes of patients,”
says Tommy
Mikkelsen, M.D., medical director of the precision medicine program and clinical
trials at Henry Ford Health System. “They’re not experiments on people, but with people, in order to gather solid data. From that, we can make
treatment recommendations going forward.”

“A clinical trial is a voluntary research study
that’s being conducted in humans with the goal of answering questions about new
medical treatments, devices or procedures,” adds Tiffany Pearce, director of
clinical trials at Henry Ford Health System.

“They help us answer questions like, ‘Does a
treatment work?’ ‘Does it have side effects?’ or ‘Does it work better than
other treatments?’”

At any time, thousands of clinical trials are taking
place to find solutions to all kinds of diseases and conditions such as insomnia, depression
or – as many people know – cancer.

Below, Pearce answers some of the most frequently
asked questions surrounding clinical trials and how to determine whether or not
participating in one is right for you.

Q: How does a
clinical trial typically work?

A: Every clinical trial is conducted according to a very
rigid plan that outlines what types of patients can be included in the trial, which
procedures will be done, what drugs and dosages will be given, and what results
will be measured to determine the effectiveness of the trial. It also describes
what type of information will be collected and the length of the study.

Q: How do patients
get involved in clinical trials?

A: As a patient, the best place to start is to talk with your care team about your interest in clinical trials. They’re the best ones to guide you through your treatment options and outline which clinical trials you might viably consider. Most of the time, clinical trials have strict requirements for the groups of people they wish to study. If you want to participate, you’ll be screened to see if you match the requirements (age, gender, family history, stage of disease, etc.) and then you’ll be fully informed of trial’s details. Once provide your consent, you’ll be enrolled.

Q: Why do people opt
in/out of clinical trials?

A: When considering a clinical trial, patients need to
consider the risks and benefits. Some
patients opt into trials with the hope of improving or advancing medical care.
Patients also enroll because they feel the trial offers the best or more
effective treatment for their illness than what is currently available.
Patients may also choose a trial because previous therapy for their condition
wasn’t effective, or maybe there’s no treatment available for their health
problem.

Q: What are the risks and benefits of enrolling in
a clinical trial?

A: There can be a
lot of unknowns with a clinical trial. You may experience unique side effects,
the trial may not improve your health condition or it may have no effect
compared to standard treatment. Some trials can also demand more of your time
than a standard treatment plan.

Alternatively, a
clinical trial gives you access to new treatments and technologies that may not
be available any other way or be available to the general public for years.
Also, clinical trial participants are often closely monitored, which means you
may receive more care or advice during the trial.

A: Every trial is different, but if certain actions or
procedures are required of you, they will be outlined in your consent forms.

Q: Do I
have to pay out of pocket costs to participate in a clinical trial?

Most of the time, a patient does not have to pay
to participate in a clinical trial (nor will they be paid for their
participation). That said, there are two types of costs associated with a
clinical trial: 1) Routine patient care costs, such as doctor visits, hospital
stays and lab tests. 2) Research costs such as the cost of the study drug or
tests performed for research purposes. Insurance companies are not required to
cover research costs, though they are often covered by a trial’s sponsor.

Phase I trials test an experimental treatment on a small
group (usually fewer than 50) to determine its safety, side effects and proper
dosage.

Phase II trials involve more people and tend to focus more
on the effectiveness of a new medicine or treatment (i.e. is this really
working or not?)

Phase III trials expand treatments further to include larger
(and more diverse) populations. At this point, a new drug or treatment is
usually approved by an organization like the FDA.

Phase IV trials are also known as the post-marketing surveillance stage and monitor the long-term effects of the medication or treatment in question.

Q: How do you know if
a clinical trial is safe?

A: Every clinical trial is approved and monitored by the
Institutional Review Board (IRB), which is designed to ensure patient safety
and protect the rights and privacy of human subjects during a research study.

Participating in a clinical trial can be an
exciting experience. After all, you’re helping to advance the field of medicine
and help medical professionals learn how to help others in the future. Without
eager participants (and curious researchers), the medicines and technologies we
use today might never have left the research lab.

To speak with a representative from the Henry Ford Clinical Trials office, call (313) 916-1784.

Tiffany
Pearce is the director of clinical trials at Henry Ford Health System.

Dr. Tommy
Mikkelsen is a neurologist and medical director of the precision medicine
program and clinical trials at Henry Ford Health System specializing in
neuro-oncology, brain tumors and clinical trials.

A health and wellness blog produced by Henry Ford Health System, and designed to share our knowledge on a variety of topics – from tips on eating healthy, staying fit and reducing stress to advice on chronic disease management and news on medical research and health technology.